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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
510(k) Number K943486
Device Name ORAFIX SPECIAL DENTURE ADHESIVE
Applicant
Smithkline Beecham Corp.
1500 Littleton Rd.
Parsippany,  NJ  07054
Applicant Contact ANTHONY G AMITRANO
Correspondent
Smithkline Beecham Corp.
1500 Littleton Rd.
Parsippany,  NJ  07054
Correspondent Contact ANTHONY G AMITRANO
Regulation Number872.3490
Classification Product Code
KOO  
Date Received07/19/1994
Decision Date 11/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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